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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Mobile Medical Applications Draft Guidance.” The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment on the following topics: FDA's recently issued draft guidance document entitled “Mobile Medical Applications,” how FDA should approach accessories and particularly mobile medical applications that are accessories to other medical devices, and standalone software that provides clinical decision support.

Date and Time: The public workshop will be held on September 12 and 13, 2011. Submit electronic and written comments by October 19, 2011.

Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.

Registration and Requests for Oral Presentations: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this workshop must register online by 5 p.m. on September 9, 2011. For those without Internet access, please call the contact person to register.

Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should register as soon as possible.

If you need special accommodations due to a disability, please contact Susan Monahan (e-mail: Susan.Monahan@fda.hhs.gov or phone: 301-796-5661) no later than September 9, 2011.

This workshop will also be provided via webcast. Persons interested in participating by webcast must register online by 5 p.m. on September 9, 2011. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but view using one connection per location. Webcast participants will be sent connection Start Printed Page 50232requirements. To register for the public workshop—whether attending in person or for the webcast—please visit http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​default.htm (or go to the FDA Medical Devices News & Events—Workshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, telephone, and FAX number. Registrants will receive confirmation once they have been accepted. You will be notified if you are on a waitlist.

This workshop includes a public comment session. During online registration you may indicate if you wish to make an oral presentation during a public comment session at the public workshop, and which topic you wish to address in your presentation. FDA has included topics for comment in this document. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. All requests to make oral presentations, as well as presentation materials, must be sent to the contact person by September 9, 2011.

Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments until October 19, 2011. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

End PreambleStart Supplemental Information

SUPPLEMENTARY INFORMATION:

I. What is the background and purpose for holding this public workshop?

The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment from interested stakeholders on the following issues previously raised in the notice of availability for the draft guidance (76 FR 43689, July 21, 2011): FDA's recently-issued draft guidance document entitled “Mobile Medical Applications,” how FDA should approach accessories and particularly mobile medical applications that are accessories to other medical devices, and stand-alone software that provides clinical decision support.

At this time, FDA intends to apply its regulatory requirements to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). For purposes of the draft guidance and the public workshop discussion, a “mobile medical app” is a mobile application that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)) [1]
; and either:

Is used as an accessory to a regulated medical device; or

Transforms a mobile platform into a regulated medical device.

This narrowly-tailored approach focuses on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device.

Although some mobile apps that do not meet the definition of a mobile medical app may meet the FD&C Act's definition of a device, FDA intends to exercise enforcement discretion [2]
towards those mobile apps.

II. What are the specific issues for discussion and public comment at the public workshop?

We welcome comments on all aspects of the draft guidance as well as the following specific issues:

1. FDA generally considers extensions of medical devices as accessories to those medical devices. Accessories have been typically regulated under the same classification as the connected medical device. However, we recognize potential limitations to this policy for mobile medical apps. FDA seeks comment on how the Agency should approach accessories and particularly mobile medical apps that are accessories to other medical devices so safety and effectiveness can be reasonably assured. For example, one possible approach could be the following:

An accessory that does not change the intended use of the connected device, but aids in the use of the connected medical device could be regulated as class I. For example, such an accessory would be similar to an infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that simply supports the intended use of a regulated medical device could be classified as class I with design controls as part of the quality systems requirements;

An accessory that extends the intended use of the connected medical device could be classified with the connected device. For example, if a mobile medical app that performs more detailed analysis than the connected medical device while maintaining the original intended use, which is data analysis, could be classified in the same classification as the connected medical device; and

An accessory that creates a new intended use from that of the connected device(s) could be classified according to the risk posed to patient safety by the new intended use, for example, if the intended use of a mobile medical app is to provide prognosis relating to a certain disease or condition and the mobile medical app is connected to a device that does not have that intended use, the mobile medical app may have a different level of risk than the connected device, resulting in a different classification to assure safety and effectiveness of the mobile medical app.

2. FDA has not addressed in its draft guidance, “Mobile Medical Applications,” stand-alone software (mobile or traditional workstation) that analyzes, processes, or interprets medical device data (collected Start Printed Page 50233electronically or through manual entry of the device data) for purposes of automatically assessing patient specific data or for providing support in making clinical decisions. FDA plans to address such stand-alone software in a separate guidance. In order to provide a reasonable assurance of the safety and effectiveness of such software, and to ensure consistency between the draft guidance, “Mobile Medical Applications,” and the planned guidance on stand-alone software that provides clinical decision support (CDS), FDA is seeking comment on the following issues:

What factors should FDA consider in determining the risk classification of different types of software that provide CDS functionality? Please provide examples of how those factors would be applied for such software that you believe should be in class I, class II, and class III;

How should the FDA assess stand-alone software that provides CDS functionality, to assure reasonable safety and effectiveness? For example, to what extent can FDA rely on a manufacturer's demonstration that it has a robust quality system with appropriate quality assurance and design controls? Under what circumstances should the submission of clinical data be required?; and

Are there specific controls that manufacturers should implement that could change the risk classification or reduce the premarket data requirements for particular types of stand-alone software that provide CDS functionality?

IV. Will there be transcripts of the meeting?

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

Start Signature

Dated: August 9, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.

End SignatureEnd Supplemental Information

Footnotes

1.
Products that are built with or consist of computer and/or software components or applications are subject to regulation as devices when they meet the definition of a device in section 201(h) of the FD&C Act. That provision defines a device as “* * * an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent * * *”, that is “* * * intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man * * * ” or “* * * intended to affect the structure or any function of the body of man or other animals * * *”.

2.
This means that FDA intends to exercise its discretion to decline to pursue enforcement actions for violations of the FD&C Act and applicable regulations by a manufacturer of a mobile medical app, as specified in the draft guidance, “Mobile Medical Applications.” This does not constitute a change in the requirements of the FD&C Act or any applicable regulations.